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Senior Executive / Specialist – Aggregate Reporting


Bengaluru, India

Hyderabad, India

Primary Job Responsibilities :

  • Responsible for drafting of PBRER/PSUR for innovator products and devices for EMA and other local health authorities as per the requirement.
  • Co-ordinate with various stakeholders and conduct planning meeting and obtain the inputs required for drafting the PBRER/PSUR reports.
  • Address the comments of stakeholders and submit the clean copy of the report to Sponsor.
  • Manage the production of aggregate reports such as PBRER/PSUR etc. for assigned products – medium to high complexity reports.
  • Perform quality reviews for the reports prepared by the peer aggregate report writers.
  • Ensure preparation of timely, quality aggregate reports for assigned products.
  • Liaise with relevant stake holders as appropriate for preparing report content.
  • Data quality review /correction.
  • Quality review of team members aggregate reports.
  • Attend team meeting, department meetings, required training and relevant activities.
  • Awareness of global culture and drug safety.

 Secondary Job Responsibilities :

  • Complete all assigned trainings within specified timelines in the internal training tool and sponsor training tool.
  • Attend team meeting, department meetings, required training and relevant activities.
  • Keeping the trackers up-to-date and timely archival of documents in SharePoint.

Candidate Profile :

  • Should have done MPharm / PharmD / BDS / BPharm / MSc in Life Sciences.
  • Should have 2-6 years of experience.
  • Good understanding of ICH E2C (R2) and GVP module 7 guideline.
  • Hands on experience on drafting of PBRER/PSUR for innovator products.
  • Excellent written and verbal English communication skills.
  • Competent in use of desktop applications: Microsoft Excel, Word and PowerPoint.

Role Application

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  • Max. file size: 30 MB.